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Clinical Trial · NCT01864083
FACBC PET and PEM as a Staging Tool and Indicator of Therapeutic Response in Breast Cancer Patients
Overview
This study has been designed to help us determine if FACBC PET or PEM can accurately evaluate how far the breast cancer has spread in the breast. Also, to help determine if FACBC PET or PEM can accurately measure your response to chemotherapy.
Sponsor
Memorial Sloan Kettering Cancer Center
Phase
Early Phase 1
Contacts
Gary Ulaner, MD (PRINCIPAL_INVESTIGATOR)
ClinicalTrials.gov
NCT01864083Drug / Compound
FACBC
Isotope(s):
FLUORINE-18
Radioisotope: F-18
Theranostic Role: PET Imaging
T1/2 (Half-Life): 1.8 Hours
Decay Mode: POSITRON β+ (96.7%), ELECTRON CAPTURE (3.3%), GAMMA 511 keV
Energy: Eβ+ 635 keV
Range: N/A
Decay Daughters: O18 (Stable)
Status: FDA Approvals: FDG (Cancer 2005): GLUDEF®, METATRACE® AXUMIN® (2016), PYLARIFY® (2023), POSLUMA® (2024)
Target(s):
- Amino Acid Transport
Ligand Class: Small Molecules
Eligibility
Inclusion
- No prior therapy for IDC or ILC
- Women presenting for evaluation at MSKCC with biopsy proven primary IDC or ILC
- Clinical need for neoadjuvant chemotherapy (Group B only)
- Clinical need for local disease staging with breast MR (Group A only)
Exclusion
- Men
- Patients who have already started treatment for the current malignancy
- Patients may only participate in group #1 or group #2, but not both
- Patients who are known to have contraindication for MRI (e.g. metal implants)
- Patients who cannot undergo PET scanning (i.e. because of weight limits)
- Pregnancy or lactation
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